510(k) · Cleared
ClearedRhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smwmed, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Apr 23, 2026 as substantially equivalent to K231289 (Wellysis Corp., 2023) and 1 other predicate after a 266-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Apr 23, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K950944 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
- 6 generations backK993618 DXP1000 Holter RecorderBraemar Corp. · 1999
- 5 generations backK113176 Mysense HeartCardiac Science Corporation · 2011
- 4 generations backK131190 MypatchDms-Service, LLC · 2013
- 3 generations backK160704 myPatch-sDms-Service, LLC · 2016
- 2 generations backK171410 ePatchBraemar Manufacturing, LLC · 2018
- 1 generation backK231289 S-Patch Ex Wearable ECG PatchWellysis Corp. · 2023
- This deviceK252389 Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | 1996 | — |
| −6 | K993618 | DXP1000 Holter Recorder | Braemar Corp. | 1999 | — |
| −5 | K113176 | Mysense Heart | Cardiac Science Corporation | 2011 | — |
| −4 | K131190 | Mypatch | Dms-Service, LLC | 2013 | — |
| −3 | K160704 | myPatch-s | Dms-Service, LLC | 2016 | — |
| −2 | K171410 | ePatch | Braemar Manufacturing, LLC | 2018 | — |
| −1 | K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | 2023 | — |
| 0 (this device) | K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) | Smwmed, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSH device
- #1 K260157 LifeLens Physiological Monitorscore 18.0 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231289 | S-Patch Ex Wearable ECG PatchSummary page 5…code Number Date S-Patch Ex Wearable ECG 1. Wellysis Corp. DSH K231289 08/30/2023 Patch Braemar 2. Manufacturing, ePatch®… | 2023 |
| * | K171410 | ePatchSummary page 5…K231289 08/30/2023 Patch Braemar 2. Manufacturing, ePatch® DSH K171410 01/04/2018 LLC IV. Device Description The Rhythm Master ECG Patch is a lightweight, compact cardiac mon… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K231289.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. It is intended for use by patients 18 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252389: Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252389
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026